ADC Contract Manufacturing Market (3rd Edition), 2018-2030

LONDON, Oct. 2, 2018 /PRNewswire/ -- Antibody drug conjugates (ADCs) are one of the most popular classes of targeted therapeutic

agents and have captured the attention of both large and small pharmaceutical companies, and academic / research institutions across the world. Fundamentally, these complex biotherapeutic entities represent the combination of the target specificity of

an antibody and the cytotoxic potential of a chemotherapy drug; such conjugates are believed to be more efficient and effective in specifically identifying and eliminating cells / pathogens that are associated with disease(s). Since the approval of first ADC (MYLOTARG™) in 2000 and its subsequent withdrawal in the year 2010, the ADC market has evolved considerably. Presently, there are four approved ADCs in the market: BESPONSA® (2017), MYLOTARG™ (2017, reapproval), KADCYLA® (2013) and ADCETRIS® (2011). In fact, in the last 4-5 years, the market has witnessed an increasing interest from drug developers and healthcare investors alike. This is justified by the fact that currently there are close to 200 unique ADC product candidates in the clinical / preclinical phase of development.Download the full report: https://www.reportbuyer.com/product/3290025
Owing to the fact that these novel conjugates are highly potent toxic molecules, their manufacturing requires elaborate technical capabilities, along with the required expertise and manufacturing acumen related to both biologics and highly potent chemical substances. Specifically, the development of an antibody requires experience in protein engineering, cell line development, bioprocess development and related scale-up techniques. The production of the cytotoxic payloads that are used in ADCs requires specialized manufacturing facilities and equipment, highly contained production environments and experts in advanced synthetic chemistry and purification techniques. In addition, ADC developers require access to state-of-art linker technologies and must possess the ability to carry out the bioconjugation of the antibody to the cytotoxic drug. Due to the aforementioned challenges, stakeholders generally don't opt for manufacturing ADCs in-house. In fact, some of the leading players in this domain are dependent on contract manufacturers for the supply of one or more components of their ADC product candidates. Although some big pharma companies carry out in-house manufacturing of their ADC products, the trend of outsourcing such operations is likely to flourish in the coming years. This trend is expected to be driven by the several small companies and start-ups that are presently involved in development of ADCs.The "ADC Contract Manufacturing Market (3rd edition), 2018-2030" report offers a comprehensive study of the current scenario and future potential of the contract manufacturing market for ADCs. The study features an in-depth analysis, highlighting the capabilities of contract services providers engaged in this domain. In addition to other elements, the study includes:- An overview of the current status of the market with respect to the players involved in the manufacturing of ADCs. It features information on headquarters, size of the company, the types of services offered (antibody manufacturing / HPAPI or cytotoxic manufacturing / linker manufacturing / conjugation / fill-finish), location of manufacturing facilities, year of establishment of company / organization, scale of operations, and additional development services offered for ADCs (proof-of-concept studies / process development and scale-up / anaytical development).- Elaborate profiles of the contract service providers that are either one-stop-shops (offering services from antibody manufacturing to fill/ finish operations) or offer conjugation services at the commercial scale. Each profile provides a brief overview of the company, its financial information, details on ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.- A comparative analysis of the key contract manufacturers based onvarious parameters, including company size, year of establishment, number of ADC manufacturing services offered, annual revenues, scale of operation, number of ADC development services offered and number of facilities for conjugation services.- An analysis of the recent investments (since 2012) made in this domain, the proceeds of which were intended to be used for the expansion or establishment of new facilities dedicated to offering ADC related services.- An analysis of the recent collaborations (since 2012) focused on manufacturing of ADCs on the basis of year in which the agreement was signed, type of agreement, key players and the geographical distribution of this activity.- An estimate of the overall ADC manufacturing / bioconjugation capacity (in grams / batch) of contract service providers based on information provided on their respective websites (wherever available) and additional data collated via secondary and primary research. The analysis highlights the distribution of global capacity by size of the company / organization (small-sized, mid-sized and large-sized) and geography (North America, Europe and Asia Pacific).- An overview of the ADCs that are already approved and those that are under development (clinical and preclinical), featuring information related to their current phase of development (wherever applicable), key target indications, developer company / organization, affiliated technology provider(s) and the type(s) of cytotoxin(s) and linker(s) used.- A review of the evolution of ADC conjugation technologies, highlighting the various types pf approaches that have been adopted in the past, and the different generations of linkers. It also highlights the competition between contemporary technology platforms.- A comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). It provides details related to the different types of payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, current trial status, phase of development, number of patients enrolled and duration of the (recently initiated) trials (2015 onwards).- An informed estimate of the annual demand for ADC products (in grams), taking into account commercial, as well as clinical scale requirements, based on parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.- A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, featuring a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on the overall ADC contract manufacturing market.One of the key objectives of this report was to evaluate the current opportunity and the future potential of the ADC contract manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2018-2030. In addition, we have provided the likely distribution of the market based on scale of operation (commercial, phase III, phase II and phase I), component / process type (antibody manufacturing, HPAPI / cytotoxic production, conjugation / linker and fill / finish), target indications (solid tumors and hematological malignancies), type of payload used (auristatin, calicheamicin (ozogamicin), duocarmycin, DXd (exatecan derivative), maytansinoid, pyrrolobenzodiazepines (talirine, tesirine) and others), type of linker used (succinimidyl 4-(n-maleimidomethyl) cyclohexane-1-carboxylate, valine-citrulline, hydrazone, valine-alanine, n-succinimidyl-4-(2-pyridyldithio) butanoate and others) and geography (North America, Europe, Asia Pacific and rest of the world).The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with following stakeholders:- Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals)- Anthony DeBoer (Director, Business Development, Synaffix)- Christian Bailly (Director of CDMO, Pierre Fabre)- Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics)- Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions)- John Burt (Chief Executive Officer, Abzena)- Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza)- Mark Wright (Site Head, Piramal Healthcare)- Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia)- Anonymous (Director, Business Development, Leading CMO)- Anonymous (Chief Executive Officer, Leading CMO)All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.Example Highlights1 - The market landscape of ADC contract manufacturers is relatively niche with a limited number of companies presently offering contract services for manufacturing / conjugation of ADC products. Of the total number of stakeholders, close to 15 players claim to be one-stop-shops, providing end-to-end services for all the steps of ADC manufacturing (antibody manufacturing to fill / finish). Examples of such players include (in alphabetical order, no specific selection criteria) Abzena, Cambrex, Catalent Pharma Solutions, Goodwin Biotechnology and MabPlex.2 - Over 80% of ADC contract manufacturers are based in either North America or Europe with facilities dedicated to ADC manufacturing / conjugation located in one or multiple regions. Around 50% of the CMOs are large companies with more than 500 employees; examples of such players include (in alphabetical order, no specific selection criteria) Novasep, Pierre Fabre, and WuXi Biologics.3 - Contract manufacturers have made significant investments in expanding their respective capabilities and working capacities in order to address the growing demand for such services. Certain companies have also established new facilities dedicated to bioconjugation and / or manufacturing of highly potent / cytotoxic compounds. Over 60 of such developments were reported during the period 2012-H1 2018; of these, 65% of the instances were facility expansion project (focused on increasing facility area, and adding new manufacturing instruments and fill / finish lines).4 - Close to 80 ADCs are currently in the clinical stages of development. These candidates have been / are being evaluated in more than 400 clinical studies, with over 70,000 patients across the globe. A significant proportion of the current demand for ADC manufacturing (both in-house and outsourced) services is also driven by the four commercially available products. Our estimates (based on parameters, such as target patient population and treatment regimen) suggest that the annual demand for ADCs (in grams) is likely to increase as more late-stage product candidates (phase II and above) receive regulatory approval over the coming decade. Currently, products being evaluated in clinical trials are estimated to contribute around 35% of the annual demand. Our projections indicate that, by 2030, commercialized products are likely to contribute to 90% of the demand for ADC manufacturing services.5 - With a limited number of players offering conjugation / ADC manufacturing services at the commercial scale, the combined global installed capacity available for manufacturing ADCs is estimated to be around 20-30 kgs. It is worth mentioning that a major share (over 90%) of the capacity is installed in facilities of mid-large CMOs, such as BSP Pharmaceuticals, Lonza, Merck / SAFC and Piramal Pharma Solutions. Around 55% of the global ADC manufacturing capacity is installed in facilities based in Europe. This is attributed to the large number of bioconjugation facilities that are presently situated in this region.6 - Driven by the rapidly evolving pipeline of ADC therapeutics and owing to the complex manufacturing requirements of such products, the trend of outsourcing is likely to persist in the foreseen future. Overall, we expect the market to grow at an annualized rate of around 11.9% during the period 2018-2030. Contract manufacturing services for antibodies (for use in ADC production) (~40%) is currently responsible for generating the major share of revenues in this market, followed by conjugation and HPAPI manufacturing.7 - In terms of payload types, the demand for services related to manufacturing auristatin and maytansinoid based ADC therapeutics is high and estimated to contribute significantly (~75%) to the market's revenues. However, the share of PBD based products is expected to grow at a relatively higher annualized rate of over 30% during the forecast period. Research MethodologyThe data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market may evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.The secondary sources of information include:Annual reportsInvestor presentationsSEC filingsIndustry databasesNews releases from company websitesGovernment policy documentsIndustry analysts' viewsWhile the focus has been on forecasting the market over the period 2018-2030, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.Chapter OutlinesChapter 2 provides an executive summary of the insights captured during our research. It offers a high level view on the likely evolution of the ADC contract manufacturing marketin the mid to long term.Chapter 3 is a general introduction to ADCs and the manufacturing requirements of such therapeutic products. It includes a detailed discussion on the structure of an ADC and its various components, manufacturing steps and associated challenges. The chapter also provides an overview of the growing trend of contract manufacturing, along with the challenges associated with supply chain and the growing demand for one-stop-shops. Further, it features a discussion on the various parameters that a sponsor company needs to consider while selecting a contract manufacturing partner.Chapter 4 provides a comprehensive overview of contract manufacturers that are actively involved in the production or conjugation of ADCs. The chapter features information on headquarters, size of the company, types of services offered (antibody manufacturing / HPAPI or cytotoxic manufacturing / linker manufacturing / conjugation / fill-finish), location of manufacturing facilities, year of establishment of company / organization, scale of operation, and additional development services offered for ADCs (proof-of-concept studies / process development and scale-up / analytical development). The chapter also includes a list of various contract manufacturers offering antibody production services along with the information on the location of their headquarters. Further, it provides a list of HPAPI / cytotoxic drug manufacturers along with the information on location of facilities dedicated to the manufacturing of such components.Chapter 5 features profiles of contract service providers that are either one-stop-shops (offering services from antibody manufacturing to fill/ finish operations) or offer conjugation services at the commercial scale. Each profile provides a brief overview of the company, its financial information, details on ADC manufacturing capabilities, location of facilities, recent developments, and a comprehensive future outlook.Chapter 6 features a detailed comparative analysis of the ADC contract manufacturers. The companies were compared on the basis of various parameters including company size, year of establishment, number of ADC manufacturing services offered, annual revenues, scale of operation, number of ADC development services offered and number of facilities for conjugation services. The results of this analysis were used to highlight the features of the most competent companies working in this domain.Chapter 7 highlightstheinvestments made by CMOs to expand or set up new facilities in order to support their ongoing operations. For each such instance, we have provided information on month / year of the development, type of development, amount invested (if available), focus area (manufacturing, analytical / development and fill / finish), scale of operation (preclinical, clinical and commercial) and location of the facility in which the investment was made.Chapter 8 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked between different players in this market. We have also discussed the different partnership models (including research agreements, manufacturing agreements, technology licensing agreements, product development agreements and acquisitions / mergers) and the most common forms of deals / agreements that have been established between 2012-H1 2018. It consists of a schematic representation showcasing the players that have established the maximum number of alliances related to the manufacturing of ADCs. Furthermore, we have provided a world map representation of the deals inked in this field, highlighting those that have been established within and across different continents.Chapter 9 features a comprehensive analysis of the overall installed manufacturing / bioconjugation capacity of contract service providers and an estimate of the quantity of ADCs that can be produced per batch. The analysis highlights the distribution of global capacity by size of the company / organization (small-sized, mid-sized and large-sized) and geography (North America, Europe and Asia Pacific).Chapter 10 provides a comprehensive overview of the market landscape of ADCs that are already approved and those that are under development (clinical and preclinical). This chapter includes information related to their current phase of development (wherever applicable), key target indications, developer company / organization, affiliated technology provider(s) and the type(s) of cytotoxin(s) and linker(s) used.Chapter 11 features an elaborate discussion and competitive analysis of the various ADC conjugation approaches. This chapter also features an overview of the evolution of these technologies, highlighting the competition between contemporary technology platforms.Chapter 12 features a comprehensive geographical clinical trial analysis of completed, ongoing and planned studies of various ADCs (approved / under development). The analysis provides details related to the different types of payloads and linkers investigated / being investigated across various geographies, based on the number of trials registered, current trial status, phase of development, number of patients enrolled and duration of the (recently initiated) trials (2015 onwards).Chapter 13 features acomprehensive analysis of the annual demand of ADCs (in grams) taking into account commercial, as well as clinical scale requirements. This was based on the parameters such as target patient population, dosing frequency and dose strength of approved products and clinical stage candidates.Chapter 14 presents a comprehensive market forecast analysis, highlighting the likely growth of the contract manufacturing market of ADCs, till 2030. The chapter provides likely distribution of the projected future opportunity based on scale of operation (commercial, phase III, phase II and phase I), component / process type (antibody, cytotoxic / linker, conjugation, fill / finish and others), target indications (solid tumors and hematological malignancies), type of payload used (auristatin, calicheamicin (ozogamicin), duocarmycin, DXd (exatecan derivative), maytansinoid, pyrrolobenzodiazepines (talirine, tesirine) and others), type of linker used (succinimidyl 4-(n-maleimidomethyl) cyclohexane-1-carboxylate, valine-citrulline, hydrazone, valine-alanine, n-succinimidyl-4-(2-pyridyldithio) butanoate and others) and geography (North America, Europe, Asia Pacific and rest of the world).Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of ADC contract manufacturing market, under a comprehensive SWOT framework.Chapter 16 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.Chapter 17 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. The chapter provides details of interviews held with Aldo Braca (Chief Executive Officer, BSP Pharmaceuticals) and Giorgio Salciarini (Technical Business Development Manager, BSP Pharmaceuticals), Anthony DeBoer (Director, Business Development, Synaffix), Christian Bailly (Director of CDMO, Pierre Fabre), Christian Rohlff (Chief Executive Officer & Founder, Oxford BioTherapeutics), Jennifer L. Mitcham (Director, Business Development, Catalent Pharma Solutions) and Stacy McDonald (Group Product Manager, Catalent Pharma Solutions), John Burt (Chief Executive Officer, Abzena), Laurent Ducry (Head of Bioconjugates Commercial Development, Lonza), Mark Wright (Site Head, Piramal Healthcare), Sasha Koniev (Chief Executive Officer & Co-Founder, Syndivia), Anonymous (Director, Business Development, Leading CMO) and Anonymous (Chief Executive Officer, Leading CMO)Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures included in the report.Chapter 19 is an appendix, which provides the list of companies and organizations mentioned in the report.Download the full report: https://www.reportbuyer.com/product/3290025
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